Posts with «health» label

DeepWell DTx is a therapy-focused game studio from the co-founder of Devolver

Therapy has an engagement problem. Despite the benefits of treatment plans and at-home exercises, people generally resist anything that feels like work, and this impedes the mental-health recovery process across the board. Clinicians have attempted to bridge this gap with various devices and reward systems, but still, it’s often incredibly difficult to motivate patients to help themselves.

Video games have the opposite problem. Players can spend hours immersed in a single digital experience, seated in one spot and lost in their own world, but they’re often branded as “lazy” for this behavior. Video games are widely viewed as a waste of time, even with growing research demonstrating the psychological benefits of play.

So, why not smash these industries together and see what happens? DeepWell Digital Therapeutics is a new video game publisher and developer from Devolver Digital co-founder Mike Wilson and medical device creator Ryan Douglas, and their goal is to alter the way people think about games and mental health. The DeepWell DTx advisory council includes more than 40 medical researchers, doctors and veteran game developers, including Tom Hall (Doom), Zoe Flower (Hellbent Games), Rami Ismail (Nuclear Throne), Lorne Lanning (Oddworld) and American McGee (American McGee's Alice).

“We fight with engagement all the time,” Douglas said. He worked for years with light therapy and other interventions designed to treat anxiety, depression and stress, but said accessibility and participation were constant battles. “And these [game developers] had cracked that code at a level that they were really hitting hard neurological reward centers in the brain, in a way that the availability to effectively change what people do and think in certain times of mental illness was vastly improved over anything I'd seen before.”

DeepWell DTx

DeepWell DTx isn’t about gamifying therapy tools or building digital experiences based on strict medical templates. Instead, the studio will analyze existing games for potential mental health benefits and, in some cases, work with interested developers to enhance these mechanics. The team will then secure approvals from regulators for these games to treat mental health issues including PTSD, anxiety, depression, OCD and addiction.

This is where Douglas’ expertise comes in. He's the founder and former CEO of medical device company Nextern and he's secured FDA approval for more than 25 medical devices over the past 15 years; he knows how to navigate this regulatory process and he sees games as a natural fit. He and Wilson started working on DeepWell about 18 months ago, in the middle of the COVID-19 pandemic.

“There's a very specific regulatory pathway for this work,” Douglas said. “So, a couple key things — agencies have done a lot of work in the last couple years to figure out how software as a medical device and specifically digital therapeutics are going to work. The FDA has been collaborative in that work. And then in this emergency time, there has been more opportunity to do the work that we need to do to get these in people's hands as quickly as possible. It's arduous but not impossible.”

Additionally, DeepWell DTx will provide a framework for players to recognize these benefits as they play – whether that’s a label on the game’s storefront, a welcome screen or another digital signal – allowing them to adjust their mindset before pressing start.

“We're super excited largely because of some intellectual property Ryan filed long before he met me, a couple years before he met me,” Wilson said. “We believe we've got a system built to enable game developers — eventually other media creators, as well — to work their magic and in a way that is already quite beneficial.”

It takes one whole minute before Wilson drops the phrase “digital psychedelics” into the conversation. This is kind of his thing; he’s an evangelist for psychedelics, with endless stories about Burning Man and the personal, therapeutic benefits he’s reaped from trips. Psychedelic therapy was a starting point for Wilson and Douglas, and they’re looking to mimic the perspective-shifting, calming effects of these substances through accessible digital experiences. They’re focused on alleviating a mental health crisis that was exacerbated by the global quarantine, using tools that people already have and naturally reach for.

“While it might not be as powerful as sitting with a macro dose of mushrooms and a couple of therapists, it might not be one session or two sessions or three, but it is an adjunct therapy that is good for you, that you might be way more likely to engage in and that the whole world has access to, even if they don't have access to health care,” Wilson said. “These will be interventions that are helpful to people that are just paying regular game prices.”

Literally every game is up for review from the DeepWell DTx crew, from platformers and narrative adventures to RPGs and shooters, and interested developers can apply starting today. There’s also an in-house development arm of the DeepWell beast, and its first game is already halfway through development, with a few others in pre-production. The first DeepWell games are due to start rolling out in 2023.

Patient dies two months after groundbreaking pig heart transplant

David Bennett, the first human to successfully undergo a heart transplant involving a genetically modified pig heart, has died, according to The New York Times. He was 57. It’s unclear if his body rejected the organ doctors implanted in January. “There was no obvious cause identified at the time of his death,” a spokesperson for the University of Maryland School of Medicine, the hospital that performed the procedure, told the outlet. Physicians plan to carry out a full evaluation before publishing their findings in a peer-reviewed journal.

When Bennett’s transplant was first announced, doctors treated the news with cautious optimism. And for a time, it looked like that feeling was warranted. Not only did Bennett’s body not immediately reject the organ, but he was also able to take part in physical therapy and spend time with his family. And while he was never discharged from the hospital, he did survive two months with the genetically modified organ beating in place of his human heart.

Even if doctors determine the cause of death was organ rejection, that’s no small milestone. Stephanie Fae Beauclair, one of the most famous patients to undergo a xenotransplantation procedure, survived for 21 days before her body rejected her adopted baboon heart. Part of the reason doctors were hopeful the procedure would work is that there’s a dire organ shortage in the US and many others parts of the world. According to the Health Resources and Services Administration, about 17 Americans die every day waiting for an organ transplant.

Eargo 6: Tiny hearing aids that don't scrimp on features

In the world of hearing aids, Eargo stands out for a few reasons. Not least because of its different approach, but also because of its rapid, annual release cycle. It’s all part of how Eargo operates more like a technology company instead of a stuffy medical-device provider. This year’s model? It’s number 6, and it’s not a huge leap from last year’s, but it’s still a notable one. One that pushes Eargo ever nearer to feature parity with the competition it seeks to outdo while maintaining its tiny, tiny form factor.

It’s that form factor that is both beneficial and binding. To be clear, “invisible in canal” (IIC) hearing aids are not unique to Eargo, but they do tend to come with tradeoffs such as no Bluetooth connectivity, reduced battery life and, of course, a lack of on-device controls (such as volume). To Eargo’s credit, it has found ways to sidestep most of these challenges with each new product, and this time it’s automatic profile switching – dubbed “Sound Adjust” — that gets crossed off the list of things that an Eargo can’t do.

First, a reminder of some of the things previous models could already do. Despite their size you can configure Eargos via the companion app. Initially, this was limited to placing them in the (Bluetooth-enabled) charging case, but newer models can be adjusted while wearing them thanks to the clever use of ultrasonic commands. You can also switch preset profiles using a gesture (double-tapping your tragus). All Eargos are also rechargeable with a charging case so you don’t need to fiddle with batteries.

More recently, since last year’s model, you’ve been able to customize the audio profile of the hearing aids to match your own unique hearing needs, which is perhaps the most significant update for most people. As a direct-to-customer product there’s usually no audiologist fitting these for you, so the app-based process goes a long way to eliminating that rather obvious negative and probably also does a good job of convincing fence-sitters that these are serious hearing aids and not fancy personal amplifiers (all Eargo products have been FDA approved hearing aids).

James Trew / Engadget

When it comes to testing out the new Sound Adjust feature it’s not quite as simple as monitoring the companion app and watching it update as a profile changes. Thanks to how the Eargos communicate with the app (via the aforementioned ultrasound) the phone needs to be very close to the hearing aids with the volume up (above 75 percent) for it to make changes. Of course, that’s just one way. Right now, there’s no real way for the buds themselves to communicate back to the app. So how do we know when the hearing aids change modes?

As a crude test I left the Eargos on the “Normal” preset and then simulated a noisy room by playing some restaurant sounds over a nearby speaker. I can’t be certain what changes the device made, but compared to the same test wearing the previous model (without Sound Adjust) the noise did seem less jarring. The sharp sound of cutlery against plate was more pronounced in the older model than it was in the Eargo 6.

There is another, perhaps more immediately observable difference this time around and that’s the noise reduction, which seems much improved. As before you can decide how much noise reduction to apply from three different settings (low to high) or disable it if you prefer. It’s not obvious how much this feature impacts the battery life. I was able to get a full day’s use out of them with it activated and room to spare, so I don’t see why you wouldn’t use it — it really does make the hearing experience more natural.

These new features definitely add some finesse to the whole experience. They're also more practical updates, too. There’s a new “mask mode” which, and I mean this optimistically, I hope doesn’t remain useful for much longer but it’s there nonetheless. Another practicality is that the Eargo 6 is rated IPX7 for water resistance: finally, you can take a shower with these things in. With water-resistant earbuds/headphones, stepping into the shower with them on is a novelty, but with a hearing device you want to put on forget about, not having to remove them for a shower just gives you one less thing to worry about.

All these new changes increase the viability of the Eargo 6 as a replacement for whatever legacy device you might be using currently. Or, if you sense you could benefit from hearing assistance but the thought of a trip to the audiologist or haggling with insurance has been putting you off, these are about as easy an option you can find.

James Trew / Engadget

I do wish they were a little more comfortable for extended use. In general, they are fine – even for all-day wearing. But some days, my ears can feel a little more blocked than others and when this happens, I can sense some fatigue after a couple of hours with the Eargo inside. This can be further aggravated by eating, which reminds you how connected many of the muscles in our jaw and ear are.

It would also be nice to know when the Eargo have reached their maximum or minimum volume. There are controls in the app for adjusting them together and separately (perfect for my unilateral hearing loss) but I never know when it’s at maximum, so I end up either over pressing the “+” sign to make sure I must be at max when some simple feedback could just solve the mystery. This is obviously a minor nitpick, though it can be useful for helping to get the balance right to avoid going so loud as to create feedback, which does occur at higher volumes (on most hearing aids).

As always, if these sound like they might be helpful to you, you can buy them directly from the Eargo website for $2,950 (financing is available). As to whether this could be covered by your insurance, that’s less clear/something you’ll need to confirm with your provider.

AI discovery could advance the treatment of spinal cord injuries

A combination of AI and robotics might help people recover from spinal cord injuries. A Rutgers-led team has used the technology to stabilize an enzyme, Chondroitinase ABC (ChABC), that can degrade scar tissue from spinal cord injuries and encourage tissue regeneration. Where the enzyme only lasted for a few hours at body temperatures, it now lasts over a week — enough to have a more substantial effect.

The researchers started by using machine learning to identify synthetic copolymers (artificial polymers made from more than one monomer) that would last the longest inside a human. Liquid-handling robotics synthesized the copolymers and conducted the tests. This was one of the "first times" AI and robotics have been used in tandem to produce therapeutic proteins that were effective to such a degree, according to Rutgers assistant professor and lead study investigator Adam Gormley.

The stabilized enzyme doesn't amount to a functional treatment for spinal cord injuries, at least not yet. The scientists noted their tech pairing created a "promising pathway" toward longer-term tissue regeneration, not the solution itself. Even so, this project highlights one of the advantages of using AI to develop treatments. Algorithms can find compositions that would be difficult or time-consuming to locate for human researchers, making therapies practical where they weren't an option before.

Amazon ends mask requirements regardless of vaccine status

Earlier this month, Amazon announced that vaccinated warehouse workers (but not unvaccinated ones) were no longer required to wear masks. Now, the company is making face masks optional at its operations facilities across the US regardless of vaccination status starting today, according to a notice sent to workers seen by CNBC. "[This] is an exciting step in our path to normal operations," the letter states.

Workers will still have to mask up in states that mandate mask usage at work regardless of vaccination status, including Hawaii, Illinois, Oregon and Washington. Other states like California only require unvaccinated individuals to wear masks. 

The move comes amid a steep drop in Omicron COVID-19 infections across the US. Amazon confirmed that the notice was real, but told CNBC it still strongly recommends that unvaccinated employees continue to wear masks. 

Amazon had previously dropped mask restrictions toward the end of the COVID-19 Delta variant outbreak, but was forced to revive them in December as Omicron began to surge. Unlike Google and other tech companies, Amazon never required vaccinations for workers. 

The Centers for Disease Control and Prevention (CDC) released new guidance last week allowing around 70 percent of Americans to remove face coverings in areas where COVID-19 hospitalizations were low. However, some medical professionals are still concerned about protection for the elderly, immunocompromised and other vulnerable individuals. 

Disability organizations call on DOJ to finalize online accessibility rules

The American Council of the Blind, National Disability Rights Network, National Federation of the Blind and more than 170 other disability organizations signed a letter published today, calling for the Department of Justice to finalize rules for online accessibility. According to the letter, the rulemaking process began in 2010 "under Titles II and III of the ADA" but was withdrawn in 2017. Last year, US representative Ted Budd (R-NC) led the re-introduction of a bill proposing an Online Accessibility Act, which was initially introduced in October 2020.

In today's letter, addressed to assistant attorney general Kristen Clarke, the signees urged "the Department of Justice to maintain this rulemaking process as a priority and finalize a rule by the end of the current administration." It states that while the DoJ has held that the Americans with Disabilities Act (ADA) includes websites and other technologies critical to accessing a business' services, it has "failed to define when and how they should be accessible."

Director of advocacy and government affairs for the American Council of the Blind Clark Rachfal told Engadget that at the moment, the DoJ enforces accessibility online "on a case-by-case basis." 

"This is equivalent to enforcing the Americans with Disabilities Act for the physical build environment by going door-to-door along main street," he said. The signatories of this letter want the DOJ to create enforceable accessibility standards "to ensure equal access to telehealth, distance learning, remote work, and online commerce for all people with disabilities," he added.

Efforts to come up with these rules have ebbed and flowed. The letter noted that "In 2018, the Department reconfirmed its position that the ADA applies to the internet but never completed rulemakings that were begun in 2010 under Titles II and III of the ADA and withdrawn in 2017."

The result is an online world where people with disabilities struggle to get their needs met. According to WebAIM (Web Accessibility In Mind), about 97 percent of the 1 million pages evaluated had WCAG 2 (Web Content Accessibility Guidelines) failures. These issues ranged from using low contrast text and missing form input labels to empty buttons and missing alt text for images.

zlikovec via Getty Images

"The absence of digital accessibility regulations in the intervening time period has resulted in persistent exclusion of people with disabilities from digital spaces covered by the ADA," the letter notes. It also highlights issues like "persistent barriers in telehealth accessibility," particularly for deaf users. While there haven't been quantitative studies on intersectional disabilities and how they relate to online accessibility, the letter states "anecdotal reports suggest that the vast majority of DeafBlind people are completely unable to utilize telehealth as it currently exists."

An American Foundation for the Blind study that's cited in the letter found that almost 60 percent of educators surveyed in Fall 2020 reported "their blind and low vision students could not access one or more of the digital learning tools they were expected to use in class." 

As the world increasingly lives and conducts business online, it's crucial that the digital world is accessible by design. The letter points out that "These findings are neither exhaustive of all website-related issues nor comprehensive of the entire disability community." There's a lot of work and research still to be done. 

"The disability community is large and diverse, facing access issues that continue to grow and evolve with the ever-changing landscape of websites and applications." Having a set of rules in place will help enable clearer communication and implementation of the tools that will make websites (and apps) accessible to all. 

Apple's latest women's health study results focus on PCOS

Apple continues to release findings from its ongoing Women's Health study, and is announcing updated results today ahead of International Women's Day (March 8th). The report, published on Harvard's website, reveals some insights on polycystic ovary syndrome (PCOS) and cardiovascular health, based on data from more than 37,000 participants. 

Apple and Harvard found that its participants who had received PCOS diagnoses tended to be diagnosed between ages 14 and 35, with the median age being 22 years old. They were also more likely to report a family history of the syndrome and have unpredictable menstrual cycles after their first periods.

According to the report, more than 70 percent of participants without PCOS diagnoses said their menstrual cycles became regular within four years of their first period, while just 43 percent of those with PCOS experienced the same. In fact, 49 percent of participants with PCOS diagnoses never had regular menstrual cycles or only got regularity after using hormones. 

The study also looked at the health conditions related to PCOS. It reported that participants with PCOS diagnoses were four times more likely to have pre-diabetic conditions, three times more likely to have Type 2 diabetes and twice as likely to have high blood pressure and high cholesterol. It also said irregular heartbeats or arrhythmia was more common among participants with PCOS diagnoses than those without. 

Apple Women’s Health Study - Harvard T.H. Chan School of Public Health.

Apple did caution that these were preliminary insights. Data was gleaned from medical history surveys completed by more than 37,000 participants enrolled from November 2019 through December 2021. Of those who completed the medical history surveys, about 30,000 also filled out reproductive history surveys and answered questions about their menstrual cycles over time. 

According to co-principal investigator Dr. Shruthi Mahalingaiah, "The Apple Women’s Health Study is one of the first studies where we can look at the connection between menstrual health, polycystic ovary syndrome, and heart health at a population level.”

Mahalingaiah also said "Despite the association between PCOS and heart-related conditions, historically, research studies about heart health have not included information about menstrual cycles," adding that the study "is important for having a better understanding of PCOS and its health impacts, including for people with PCOS and those that might have PCOS, but do not know.”

Looking forward, Apple and Harvard want to "create a larger foundational data set on PCOS, with self-tracked variables, and its connection with heart health."

"Our hope is that by expanding the understanding of the public health burden of PCOS, we can create research models that can be applied to further scientific understanding of other health conditions and the burden of other diseases,” Mahalingaiah said.

MIT study finds neurons in epilepsy patients that only respond to singing

A study by MIT scientists on a group of epilepsy patients discovered that a specific group of neurons in their brains respond only to singing — and not to instrumental music or any other type of sound. The findings of the study were published today in the science journal Current Biology. Scientists are still working to nail down the implications of the study for epilepsy patients, some of whom rely on music as a form of therapy to reduce seizures.

“The work provides evidence for relatively fine-grained segregation of function within the auditory cortex, in a way that aligns with an intuitive distinction within music,” says Sam Norman-Haignere, the lead author of the study and assistant professor of neuroscience at the University of Rochester Medical Center.

Given how small and specific the study's sample size is (fifteen people), there's not much we can conclude from this single study alone. But it will likely advance further studies on the link between neuroscience, epilepsy and music in the future.

The study’s participants were a group of fifteen epilepsy patients, all whom consented to have electrodes implanted in their skull. They were then asked to listen to hundreds of different sounds, both natural and synthesized. Scientists, assisted by fMRI, or functional magnetic resonance imaging, observed how neurons in the auditory cortex of participants reacted to each sound.

Back in 2015, the same researchers used fMRI imaging to identify what they believe are a group of neurons that respond only to music. 

The neurons only elicited mild reactions when hearing the sound of human voices, but fired up at the sound of instrumental or vocal music. In the new study, the researchers found that there was a special subset of neurons right next to the original group that specifically lights up when the brain hears human singing.

"There's one population of neurons that responds to singing, and then very nearby is another population of neurons that responds broadly to lots of music. At the scale of fMRI, they're so close that you can't disentangle them, but with intracranial recordings, we get additional resolution, and that's what we believe allowed us to pick them apart," says Norman-Haignere.

The research could also advance our understanding of the link between music and epilepsy. While certain kinds of music can reduce the number of seizures that epilepsy patients suffer from, some rare cases of epilepsy can also be provoked by music. One recent study published in Scientific Reports last year found that listening to 30 seconds of Mozart’s “Sonata for Two Pianos in D Major” helped drive down the neuron activity that causes seizures in epilepsy patients.

FDA clears the first smartphone app to program insulin pump doses

Tandem Diabetes Care says the Food and Drug Administration (FDA) has cleared its smartphone app to program and cancel insulin doses from the t:slim X2 insulin pump. The company claims it's the first time the FDA has cleared a phone app for such a purpose.

The t:connect mobile app on iOS and Android will enable users to program and cancel bolus insulin doses from the pump, according to Tandem Diabetes Care. When connected to the pump, the app can display information about the last 24 hours of a user's glucose trends, changes in status (including alerts and alarms) and insulin therapy data.

Pumps typically require users to dial in insulin doses manually. Given that they are often able to view glucose readings on their handset, patients will be able to use their phone to determine how much insulin they need and then program their dose.

The FDA clearance could be a step toward a more convenient way for diabetes patients to administer insulin doses. Tandem Diabetes Care plans to offer the feature at no extra cost to new and in-warranty t:slim X2 insulin pump customers via a software update. The plan is to grant access to a limited number of users in the spring ahead of a broader rollout this summer.

Jabra's hearing enhancement earbuds will be available this month for $799

Jabra announced its Enhance Plus earbuds back in August, debuting a model that offers assistance to people with mild-to-moderate hearing loss. At the time, the company also announced that it would sell it directly to customers as a FDA-cleared self-fitting hearing aid. Later this month, Jabra will do just that. On February 25th, the company says you'll be able to purchase the Enhance Plus from select hearing care clinics for $799. 

The earbuds put "medical-grade hearing enhancement" inside a more approachable form factor that looks like a set of regular earbuds. Jabra says this device is also quite compact, 40 percent smaller than the company's Elite 7 Pro which are already very small. The Enhance Plus can be customized to fit the user's needs, including three speech filters and three listening modes. The earbuds not only help with in-person conversations but also offer the ability to take calls and listen to music — the core features of any set of earbuds. 

Four microphones work to reduce background clamor while improving the overall clarity of speech according to Jabra, so they're suitable for use in noisy settings. The company says you can expect up to 10 hours of battery life with an additional two full charges in the included case. The earbuds are also IP52 rated dust and water resistant and are equipped with on-board controls for basic functionality. 

Jabra says the Enhance Plus have FDA 510(k) clearance as a self-fitting hearing aid. This means that it will be available direct to consumers as an over-the-counter device inline with the agency's pending regulation that expands access to hearing assistance products by creating a new hearing aid category. Jabra isn't the only company with devices that fit the FDA designation for OTC products. Another example is Bose's SoundControl hearing aids, which have been available nationwide in the US for $850 since last summer. Those, however, look more like traditional hearing aids rather than earbuds. 

For now, state law may require a hearing test to make sure the Enhance Plus is right for you. If it is, the set will be available in grey and beige color options when it goes on sale later this month.